Status:
COMPLETED
Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Acute Myeloblastic Leukemia
Eligibility:
All Genders
2-65 years
Phase:
PHASE2
Brief Summary
Although transplant results for AML in complete remission (CR) at the time of transplant have improved, transplant results for non-remission AML have been quite poor. Most multi-center studies have fo...
Eligibility Criteria
Inclusion
- Disease Criteria
- AML not in remission at the time of transplant
- "Not in remission" is defined as "greater than 5.0% bone marrow blasts by aspirate morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration.
- For primary induction failure patients: Patients must have failed at least 2 induction regimens.
- For patients with relapsed disease: Patients who relapse more than 6 months after preceding remission must fail at least one reinduction regimen to be eligible. For patients in whom the preceding remission is equal to or shorter than 6 months duration, no re-induction regimen is required to qualify for this protocol.
- If the pre-transplant bone marrow aspirate and biopsy are hypoplastic (less than 10% cellularity), and blast percentages cannot be determined, the patient is eligible if the preceding bone marrow met the above criteria.
- Patients with peripheral circulating blasts or patients with extramedullary leukemia are eligible if bone marrow aspirate and biopsy meets the above criteria. Age and Organ Function Criteria
- Age: 2 to 65 years in age.
- Cardiac: LVEF ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
- Pulmonary: FEV1 and FVC capacity) ≥ 40% predicted, DLCO (corrected for hemoglobin) ≥ 40% of predicted.
- Children who are unable to cooperate for pulmonary function tests (PFTs), must have no evidence of dyspnea at rest, no exercise intolerance, and not require supplemental oxygen therapy.
- Renal: Age equal to or older than 12: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula. Age younger than 12: Either estimated or measured CrCl should be greater than 90 ml/min/1.73m2. For estimation, Schwartz formula will be used.
- Hepatic: Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); (AST)/ ALT ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN
- Performance status: Karnofsky ≥ 70%., or Lansky≥70% Consent: All patients must sign informed consent
Exclusion
- Active life-threatening cancer requiring treatment other than AML
- Non-compliant to medications.
- No appropriate caregivers identified.
- HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive
- Active life-threatening cancer requiring treatment other than AML
- Uncontrolled medical or psychiatric disorders.
- Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection
- Active central nervous system (CNS) leukemia
- Preceding allogeneic HSCT
- Receiving intensive chemotherapy within 21 days of registration.
- Patients with preceding primary myelofibrosis
- Peripheral blasts \> 10,000/μL at the time of registration
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01457885
Start Date
November 1 2011
End Date
June 14 2016
Last Update
June 2 2017
Active Locations (12)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109